deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT01415908

INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine (TLIF)

A Prospective, Multi-center, Pivotal Trial for INFUSE® Bone Graft With CAPSTONE® Spinal System and Posterior Supplemental Fixation to Treat 1- or 2-level Advanced Degenerative Disease of the Lumbosacral Spine For a TLIF Approach

Sponsor: Medtronic Spinal and Biologics

Updated 10 times since 2017 Last updated: Jan 20, 2016 Started: Jul 31, 2011 Primary completion: Sep 30, 2014 Completion: Jan 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Due to study design challenges including DMC enrollment suspension as required by the protocol stopping rules and recommended changes to the surgical technique

A PHASE3 clinical study on Lumbar Spine Degeneration, this trial is terminated or withdrawn. The trial is conducted by Medtronic Spinal and Biologics and has accumulated 10 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

Show 5 earlier versions
  1. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  4. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE3

  5. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE3

    First recorded

Jul 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medtronic Spinal and Biologics
Data source: Medtronic Spinal and Biologics

For direct contact, visit the study record on ClinicalTrials.gov .